Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000489
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
Coronary Artery Surgery Study CASS
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare coronary artery surgery with medical management in patients with coronary artery disease and to maintain a registry on all patients undergoing coronary arteriography whether operatively or medically managed
Detailed Description:
BACKGROUND
Although it was generally agreed that many patients with severe angina pectoris improved symptomatically after coronary artery surgery there was less consensus concerning for example other effects of the procedure such as its long-term benefit and the criteria for patient selection In addition there were fewer data and less agreement on the effects and proper role of this procedure in other clinical circumstances Both the surgical procedure and the prior diagnostic procedures represented substantial costs in both monetary and manpower terms moreover they entailed morbidity and mortality risks
There existed an urgent need for reliable and quantitative information regarding the effects of coronary artery surgery in patients with ischemic heart disease To be meaningful these data had to be set into the perspective of the clinical course of such patients under medical treatment
This assessment presupposed a meaningful classification of these patients and of the therapeutic interventions as well as evaluations of the effects of surgical and medical regimens in terms of mortality the quality of life and objective hemodynamic and other physiological measurements Only such information could provide sufficient background for determining the suitability of coronary artery surgery for a particular patient
In 1972 the National Heart and Lung Advisory Council identified these questions as topics of high priority and the National Heart and Lung Institute established an Ad Hoc Policy Advisory Board on Coronary Artery Surgery to assist it in developing a program of research activities In its report the Board noted a critical need for objective data on the long- and short-term effects of coronary artery surgery Requests for proposals were issued to carry out the recommendations of the Board
Planning of the trial was conducted between June 1973 and April 1975 and included protocol design the development of a manual of operations and a pilot study of the registry In August 1975 registry patients entry and randomization began at the 11 clinical centers and coordinating center Initial projections of patient population numbers were underestimated therefore five clinical centers were added to the trial in 1976
The five clinical subgroups of patients in the randomized studies included stable angina with normal resting left ventricular function stable angina with impaired left ventricular function post-myocardial infarction without angina congestive heart failure due primarily to ischemic heart disease and patients previously asymptomatic who were discovered to have serious coronary artery disease All of the above subgroups must have met specifically outlined clinical and angiographic criteria to be placed in the randomized subset The other two subsets as distinguished from subgroups of the study included those patients who were unsuitable for randomization because surgery was the treatment of choice in the judgment of many physicians and those patients for whom medical management was the treatment of choice The patients enrolled in both the registry and randomized trial were followed for a 10-year period This allowed evaluation of the primary endpoints death and myocardial infarction and the secondary endpoints angina status and quality of life
A total of 24959 patients were entered into the registry 780 patients were entered into the trial Recruitment ended in 1979 Intervention ended in June 1983 Follow-up was extended for an additional five years to June 1989 Data analysis continued through May 1995 with grant support
DESIGN NARRATIVE
Randomized non-blind sequential Some 780 patients meeting the criteria of specific subsets based on history physical exam laboratory tests catheterization and angiography were randomized to either surgical or medical therapy Primary endpoints included death and myocardial infarction
Although it was generally agreed that many patients with severe angina pectoris improved symptomatically after coronary artery surgery there was less consensus concerning for example other effects of the procedure such as its long-term benefit and the criteria for patient selection In addition there were fewer data and less agreement on the effects and proper role of this procedure in other clinical circumstances Both the surgical procedure and the prior diagnostic procedures represented substantial costs in both monetary and manpower terms moreover they entailed morbidity and mortality risks
There existed an urgent need for reliable and quantitative information regarding the effects of coronary artery surgery in patients with ischemic heart disease To be meaningful these data had to be set into the perspective of the clinical course of such patients under medical treatment
This assessment presupposed a meaningful classification of these patients and of the therapeutic interventions as well as evaluations of the effects of surgical and medical regimens in terms of mortality the quality of life and objective hemodynamic and other physiological measurements Only such information could provide sufficient background for determining the suitability of coronary artery surgery for a particular patient
In 1972 the National Heart and Lung Advisory Council identified these questions as topics of high priority and the National Heart and Lung Institute established an Ad Hoc Policy Advisory Board on Coronary Artery Surgery to assist it in developing a program of research activities In its report the Board noted a critical need for objective data on the long- and short-term effects of coronary artery surgery Requests for proposals were issued to carry out the recommendations of the Board
Planning of the trial was conducted between June 1973 and April 1975 and included protocol design the development of a manual of operations and a pilot study of the registry In August 1975 registry patients entry and randomization began at the 11 clinical centers and coordinating center Initial projections of patient population numbers were underestimated therefore five clinical centers were added to the trial in 1976
The five clinical subgroups of patients in the randomized studies included stable angina with normal resting left ventricular function stable angina with impaired left ventricular function post-myocardial infarction without angina congestive heart failure due primarily to ischemic heart disease and patients previously asymptomatic who were discovered to have serious coronary artery disease All of the above subgroups must have met specifically outlined clinical and angiographic criteria to be placed in the randomized subset The other two subsets as distinguished from subgroups of the study included those patients who were unsuitable for randomization because surgery was the treatment of choice in the judgment of many physicians and those patients for whom medical management was the treatment of choice The patients enrolled in both the registry and randomized trial were followed for a 10-year period This allowed evaluation of the primary endpoints death and myocardial infarction and the secondary endpoints angina status and quality of life
A total of 24959 patients were entered into the registry 780 patients were entered into the trial Recruitment ended in 1979 Intervention ended in June 1983 Follow-up was extended for an additional five years to June 1989 Data analysis continued through May 1995 with grant support
DESIGN NARRATIVE
Randomized non-blind sequential Some 780 patients meeting the criteria of specific subsets based on history physical exam laboratory tests catheterization and angiography were randomized to either surgical or medical therapy Primary endpoints included death and myocardial infarction
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL038941 | NIH | None | httpsreporternihgovquickSearchR01HL038941 |